Drug Safety and Pharmacovigilance Specialist at Santhera Pharmaceuticals
Santhera Pharmaceuticals (Schweiz) AG
Publication date:
18 February 2025Workload:
100%Contract type:
Permanent position- Place of work:Pratteln
Job summary
Santhera Pharmaceuticals is a Swiss company focused on rare diseases. Join us to make a meaningful impact on patients’ lives.
Tasks
- Oversee global PV systems, ensuring regulatory compliance and quality.
- Monitor drug safety for authorized and clinical-stage products.
- Manage safety reporting and collaborate with regulatory teams.
Skills
- Medical or scientific degree with 10+ years in drug safety.
- Strong leadership skills and agile mindset for prioritization.
- Excellent planning and communication skills in a fast-paced environment.
Summary from the original job ad
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Head Drug Safety and Pharmacovigilance (DS&PV) Location: Pratteln, Switzerland (Hybrid) Scope of Work
We are looking for an experienced and strategic leader to join our team as Head of DS&PV. In this role, you will oversee Santhera's global PV systems, ensuring compliance with all PV and Quality obligations as a marketing authorization holder and clinical trial sponsor. You will maintain an overview of the safety profiles for all authorized and clinical-stage products. You will also provide guidance on drug safety in development programs, including input on IBs, IMPDs, protocols, and the company's core safety information data sheet. Additionally, you will ensure adequate support and resources from the CEO and General Managers. This role reports to the Chief Medical Officer. Key Responsibilities
- Oversee Santhera's global Pharmacovigilance (PV) system, ensuring compliance with regulations and managing PV vendors and activities.
- Ensure Santhera meets its obligations as a clinical trial sponsor and marketing authorization holder, maintaining a robust PV framework.
- Monitor drug safety across all products, ensuring timely identification, escalation, and management of safety concerns.
- Oversee the execution of QPPV responsibilities, ensuring compliance with EU and global regulatory requirements, including validation oversight.
- Supervise risk management systems, the implementation of risk minimization measures, and the oversight of
- Ensure high-quality safety reporting, including PSURs, Risk Management Plans, and timely submissions to health authorities.
- Maintain oversight of company core safety information (CCSI), ensuring it reflects current scientific knowledge and regulatory recommendations.
- Collaborate with regulatory teams to address safety-related regulatory actions and respond promptly to health authority requests.
- Medical, Scientific or equivalent Degree
- At least 10 years of experience in all aspects of drug safety and pharmacovigilance (clinical development and post marketing)
- Expert knowledge of European and US Drug Safety and Pharmacovigilance requirements and strong knowledge in other geographical areas
- Expert knowledge of Drug Safety/Pharmacovigilance practices and tools (e.g. Argus Database)
- Strong leadership skills to represent DS&PV at the company level and communicate key issues and opportunities effectively.
- Agile and flexible mindset to set priorities and work efficiently within a small company.
- Excellent planning, organization, and time management skills to meet tight deadlines in a fast-paced environment.
- Strong verbal and written English communication skills, with attention to detail and a quality-oriented approach.
- Ability to work independently while being a reliable team player, managing multiple projects in a matrix environment.
